A Study to Assess the Safety of ARGX-109 in Healthy Volun... | NCT06799416

Studies
A Study to Assess the Safety of ARGX-109 in Healthy Volunteers

NCT06799416

Sponsor

argenx

Status

Completed

Last Update Posted

Sep 18, 2025Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

ARGX-109
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2025Actual

Primary Completion Date

Aug 8, 2025Actual

Completion Date

Aug 8, 2025Actual

First Submitted Date

Jan 23, 2025

First Submission Date that Met QC Criteria

Jan 23, 2025

First Posted Date

Jan 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2025

Last Update Posted Date

Sep 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body. Each participant will remain in the study for approximately 20 weeks.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARGX-109	Experimental	Participants receiving the experimental drug	Biological: ARGX-109
Placebo	Placebo Comparator	Participants receiving placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARGX-109	Biological	administrations of ARGX-109	ARGX-109
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of AEs, SAEs and AEs leading to discontinuation	AE: adverse event, SAE: serious adverse event	up to 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cmax		up to 16 weeks
Total IL-6 serum concentrations		up to 16 weeks
Incidence of ADA against ARGX-109 in serum

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

is aged 18 to 65 years, inclusive, when signing the ICF
has a body weight between 50 and 100 kg and a BMI between 18.5 and 30.0 kg/m2, inclusive

Exclusion Criteria:

Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Altasciences - Montreal - Phase I unit		Mount Royal	Quebec	H3P 3P1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided